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510(k) Data Aggregation
K Number
K143692Device Name
GranOSTM - beta tricalcium phosphate synthetic bone granules
Manufacturer
Date Cleared
2015-08-21
(240 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
TCM ASSOCIATES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Device Description
GranOS™ is a porous, resorbable osteoconductive scaffold constructed of highly pure beta tricalcium phosphate granules for use in the repair of bony defects.
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